Visible Abdominal Distension
Hospital Universitari Vall d'Hebron Research Institute · NCT06369753
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- July 30, 2025
- Record last updated
- October 31, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.
Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.
Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.
Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Being studied: Biofeedback; Placebo
Conditions: Irritable Bowel Syndrome; Dyspepsia; Functional Bloating
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- episodes of visible abdominal distension triggered by meal ingestion
Exclusion Criteria
- organic cause detected by clinical work-up
- constipation
- abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation
Recruiting US locations
G. Oppenheimer Center for Neurobiology of Stress and Resilience
Los Angeles, CA 90095
Site contact: Lin Chang, M.D. · (310) 206-0192 · LinChang@mednet.ucla.edu
Study contacts (from the official record)
- Fernando Azpiroz, MD · 34 932746259 · azpiroz.fernando@gmail.com
- Jordi Serra, MD · 34 932746259 · jordi.serra@vallhebron.cat
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